Recalls / Class II

Class IID-637-2014

Product

SEVELAMER CARBONATE Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 58468013001

Affected lot / code info

SEVELAMER CARBONATE, Tablet, 800 mg has the following codes Pedigree: AD39858_4, EXP: 5/15/2014; Pedigree: AD70629_16, EXP: 5/29/2014; Pedigree: W002778, EXP: 6/6/2014; Pedigree: W002859, EXP: 6/7/2014; Pedigree: W003029, EXP: 6/11/2014; Pedigree: AD56917_4, EXP: 5/21/2014; Pedigree: AD73627_11, EXP: 5/30/2014; Pedigree: W002710, EXP: 6/6/2014; Pedigree: W002623, EXP: 6/4/2014; Pedigree: W003491, EXP: 6/20/2014.

Why it was recalled

Labeling:Label Mixup; SEVELAMER CARBONATE Tablet, 800 mg may be potentially mislabeled as tiZANidine HCl, Tablet, 2 mg, NDC 55111017915, Pedigree: AD46265_16, EXP: 5/15/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD70629_13, EXP: 5/29/2014; QUEtiapine FUMARATE, Tablet, 100 mg, NDC 60505313301, Pedigree: W002777, EXP: 6/6/2014; VALSARTAN, Tablet, 160 mg, NDC 0007803

Recalling firm

Firm

Aidapak Services, LLC

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

14301 Se 1st St, Vancouver, Washington 98684-3501

Distribution

Quantity

3,238 Tablets

Distribution pattern

Repacked drugs were distributed in Arizona, California, Oregon, and Washington.

Timeline

Recall initiated

2013-07-02

FDA classified

2014-01-16

Posted by FDA

2014-01-22

Terminated

2014-02-07

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-637-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.